CTRI/2021/02/031249
已完成
3 期
A prospective, multicenter, double blind, placebo controlled randomized clinical trial to evaluate efficacy and safety of Meniphib tablets in female patients suffering from premenstrual syndrome.
Bhargava Phytolab0 个研究点目标入组 100 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Bhargava Phytolab
- 入组人数
- 100
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\)Subject is willing and able to give written informed consent
- •2\)Female subjects aged ââ?°Â¥ 18 and ââ?°Â¤ 45 years not attained menopause
- •3\)Subject having clinical diagnosis as per investigators judgment for Premenstrual Syndrome
- •4\)Subjects of childbearing potential should have a negative pregnancy test at Screening
- •5\)Female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study
- •Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care
- •6\)Subject is willing, able and likely to comply with all study procedures and restrictions
排除标准
- •1\)Subject is pregnant or breast\-feeding at the time of screening, or planning
- •to be pregnant during the study
- •2\)History of current or past Psychiatric Disorders
- •3\)History consistent with endometriosis
- •4\)Diagnosis of ill\-defined, obscure pelvic lesions, particularly, undiagnosed ovarian enlargement, hepatic disease as manifested by medical history
- •5\)History of mammary carcinoma
- •6\)History of pulmonary embolism or phlebothrombosis
- •7\)Undiagnosed vaginal bleeding
- •8\)Subject suffering from porphyria
- •9\)Subject suffering from uncontrolled diabetes mellitus
结局指标
主要结局
未指定
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